Vacuum pump systems for prosthetic limbs and methods of using the same

ABSTRACT

Pump systems for use in suspension of a prosthetic device from a residual limb and methods of suspending a prosthetic device from a residual limb are disclosed. The pump systems include a mechanically activated pump having a first compression member coupled to a second compression member, a compressible bladder disposed between the first and second compression members, and coupling elements that engage and couple together the first and second compression members. The mechanically activated pump may be connected with an electrically activated pump within a fluid circuit of a hybrid pump system to provide vacuum engagement between a prosthetic device and a residual limb.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of co-pending U.S. patentapplication Ser. No. 13/529,833, filed Jun. 21, 2012, and further claimsbenefits and priority of U.S. Provisional Patent Application Ser. No.61/571,233, filed Jun. 23, 2011, the disclosures of which are herebyincorporated by reference in their entirety.

CONTRACTUAL ORIGIN OF THE INVENTION

This invention was made with government support under W81XWH-10-1-0744awarded by the U.S. Army Medical Research and Material Command andH133E080009 awarded by the National Institute on Disability andRehabilitation Research (NIDDR). The government has certain rights inthe invention.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention generally relates to suspension systems forprosthetic devices, and more particularly to vacuum pump systems forprosthetic limbs that include at least a mechanically activated pump.

Discussion of the Prior Art

Various systems have been developed for coupling a prosthetic device orprosthetic limb to a residual limb. The residual limb is connected tothe prosthesis via a socket which receives and holds in place an endportion of the residual limb. Suspension is the mechanism that holds thesocket to the residual limb. Vacuum is a form of suspension that uses adifference in atmospheric pressure to hold a socket to the residuallimb. Liners help protect the residual limb tissue by providingcushioning and helping distribute the applied negative pressure in auniform manner.

Vacuum pump technology is used to suspend the socket to the residuallimb by creating a vacuum between the liner and the socket. The abilityto maintain vacuum at a relatively consistent level can help avoidundesirable movement between the socket and the residual limb whichimproves comfort and avoids soft tissue damage.

Vacuum pumps fall into two categories, namely, mechanically activated orelectrically activated. Electrically activated pumps tend to evacuateair more quickly, are able to monitor and adjust the vacuum pressure,and to automatically initiate pump operation if the vacuum pressure isnot at least at a preselected threshold. However, electrically activatedpumps include a small DC motor that requires a power source, such asdisposable or rechargeable batteries. Electrically activated pumps alsomay generate undesirable noise.

Mechanically activated pumps use the walking motion of the user tocreate vacuum. One way pressure valves permit proper maintenance ofvacuum pressure, without access to electricity. The necessary vacuum maybe maintained indefinitely as long as there are no leaks in the systemand/or the user walks occasionally. However, the mechanically activatedpumps do not provide initial evacuation of air without effort, takelonger to achieve operative vacuum levels, and typically need periodicmotion to maintain appropriate vacuum levels. Mechanically activatedpumps also tend to require a significant length for operation, as theytypically operate by using a telescoping assembly. Depending on thenumber of parallel alignment elements involved, length can be importantwithin a telescoping assembly, so as to provide adequate surfaceengagement to avoid binding. Mechanically activated pumps generally areconfigured for mounting below the knee because the pumps are too long tofit between the socket and the knee joint of the prosthetic limb, and assuch, are not as well suited for transfemoral amputees.

Mechanically activated pumps also typically use a piston within acylinder for pumping, or systems that include a flexible toroidal orring-shaped reservoir or bladder that has a relatively large cylindricaltelescopic tube running through the center, in place of a section of alower limb pylon. The tube must be relatively large and of lengthsufficient to avoid binding, while withstanding the significant stressesencountered. In turn, the reservoir must be constructed to account forthe large opening through the center.

For some users, such as military personnel with amputation who wish toreturn to active duty, there is an enhanced need to be able to maintainacceptable physical performance. An active soldier with amputation maybe in the field for a prolonged period of time, with a need to maintainproper vacuum levels for suspension, while being without access to apower source for recharging of batteries. Thus, there exists a need fora compact, quiet, unobtrusive vacuum pump system with adjustablepressure and minimal battery recharging needs that will evacuate airfrom a cavity between a socket of a prosthetic limb and a residual limb.

The present invention addresses shortcomings in prior art vacuum pumpsystems for prosthetic limbs, while providing enhanced pumping systemsthat enable more flexible design and enhanced performance.

SUMMARY OF THE INVENTION

The purpose and advantages of the invention will be set forth in andapparent from the description and drawings that follow, as well as willbe learned by practice of the claimed subject matter.

The present disclosure generally provides pump systems that includemechanically activated pumps having a lower profile design while stillbeing able to provide vacuum within the desired range of 15 mmHg to 25mmHg. The mechanically activated pumps utilize a bladder but do notrequire a large central opening for a tubular telescopic assembly. Byavoiding use of such a central tubular telescopic assembly, themechanically activated pumps of the present disclosure permit use of arelatively large diameter bladder having a greater volume and whichrequires less displacement to achieve adequate pumping capacity. Suchpumps optionally permit location above or below the knee joint in atransfemoral prosthetic limb, or compact placement within a transtibialprosthetic limb.

The mechanically activated pumps of the present disclosure may utilizefirst and second compression members, with a compressible bladderdisposed therebetween and any of a variety of coupling elements disposedabout an outer perimeter of the compressible bladder. Thus, thecompression members may be pivotally coupled in a configuration thatpermits angular displacement of a first compression member relative to asecond compression member, or in a configuration that permits the firstcompression member to translate, maintaining a parallel relationship tothe second compression member. Alternatively, the compression membersmay be coupled in a configuration that does not involve any pivotalconnection, and permits the first compression member to translaterelative to the second compression member.

To further enhance the performance of pump systems for suspension of aprosthetic limb, the present disclosure also provides pump systems thatinclude an electrically activated pump, such as of the micro pump typeutilized in exclusively electrical systems, thereby providing a modularhybrid system. A hybrid pump system may offer significant advantages,such as the desired rapid engagement upon initial donning of theprosthetic device, while not requiring solely battery power to evacuateair and to maintain appropriate vacuum levels. This may permit elongatedintervals between charging of rechargeable batteries or battery packs,or between replacement of disposable batteries. A hybrid system also mayprovide for better optimization of the size and capacities of thecomponents utilized, as the mechanically activated pump portion of ahybrid system need not be as concerned with the ability to rapidlyestablish initial evacuation solely via the mechanically activated pump,while the electrically activated pump is less likely to be cycled duringthe course of many activities that now will provide operation of amechanically activated pump. Accordingly, depending on the length of theresidual limb, it may be possible to implement a hybrid pump system ofthis disclosure within a system having a relatively short length, suchthat it could be located above the knee joint for a transfemoralamputee.

Thus, a hybrid system may utilize the respective strengths ofmechanically and electrically activated pumps to achieve superioroverall performance, while essentially also providing a redundant pumpsystem to ensure at least adequate performance for the user. Byutilizing a low profile design, the systems also permit placement abovethe knee for a transfemoral amputee, for direct interaction with asocket of a prosthetic device. The pump systems preferably have a heightof about 1.5 inches or less, to permit positioning above the knee. Itwill be appreciated that the height may be more or less, depending onthe configuration of mechanically activated pump, and whether or not thesystem includes an electrically activated pump, as well as itsconfiguration. This, in turn, helps avoid many of the hindrancesassociated with below knee systems, while permitting an inline assemblythat need not require external tubing.

Accordingly, in a first aspect, disclosed herein is a pump system foruse in suspension of a prosthetic device from a residual limb. The pumpsystem includes a mechanically activated pump having a first compressionmember coupled to a second compression member, a compressible bladderdisposed between the first and second compression members, and couplingelements that engage and couple together the first and secondcompression members, wherein all of the coupling elements are disposedabout an outer perimeter of the compressible bladder.

In a second aspect, disclosed herein is a method of suspending aprosthetic device from a residual limb. The method includes providing aprosthetic device having a socket that receives the residual limb. Themethod further includes providing a mechanically activated pump having afirst compression member coupled to a second compression member, acompressible bladder disposed between the first and second compressionmembers, and coupling elements engaging and coupling together the firstand second compression members, wherein all of the coupling elements aredisposed about an outer perimeter of the compressible bladder. Themethod also includes providing a fluid circuit in communication with thesocket and the compressible bladder, the fluid circuit being configuredto evacuate air from the socket when operating the mechanicallyactivated pump, and operating the mechanically activated pump when theprosthetic device is used to walk.

In a third aspect, disclosed herein is hybrid pump system for use insuspension of a prosthetic device from a residual limb. The hybrid pumpsystem includes a mechanically activated pump, an electrically activatedpump, and the mechanically activated pump and electrically activatedpump are connected within a fluid circuit that provides vacuumengagement between the prosthetic device and the residual limb.

It will be appreciated that the unique mechanically activated pumpsdisclosed herein provide advantageous configurations that permit lowprofile arrangements to be utilized in suspending a prosthetic devicefrom a residual limb. It also will be appreciated from this disclosurethat a mechanically activated pump may be connected to a fluid circuitthat includes an electrically activated pump, so as to create a hybridsystem for use in suspension of a prosthetic device from a residuallimb. It is contemplated that various configuration may be utilized andthe appended claims are not to be limited to the examples illustrated.

Thus, the present disclosure presents alternatives to the prior artmechanically activated pumps, as well as to systems that use only anelectrically activated pump, where the prior art systems have proven tobe less effective than desired.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and provided forpurposes of explanation only, and are not restrictive of the subjectmatter claimed. Further features and objects of the present disclosurewill become more fully apparent in the following description of thepreferred embodiments and from the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In describing the preferred embodiments, reference is made to theaccompanying drawing figures wherein like parts have like referencenumerals, and wherein:

FIG. 1A is a simplified side view of a prosthetic device in the form ofa prosthetic limb for a transfemoral amputee having a first example pumpsystem that includes a mechanically activated pump, with the pump systemalso including an electrically activated pump, so as to provide a hybridpump system.

FIG. 1B is a simplified side view of a prosthetic device in the form ofa prosthetic limb for a transtibial amputee having the pump system shownin FIG. 1A.

FIG. 1C is a side perspective view of the pump system shown in FIG. 1A.

FIG. 1D is a lower rear perspective view of the pump system shown inFIG. 1A.

FIG. 1E is a side view of the pump system shown in FIG. 1A.

FIG. 1F is an upper front perspective view of the pump system shown inFIG. 1A.

FIG. 1G is simplified top view of a layout of major components withinthe electrically activated pump of the pump system shown in FIG. 1A.

FIG. 1H is further simplified upper perspective view of a layout ofmajor components within the electrically activated pump of the pumpsystem shown in FIG. 1A.

FIG. 1I is an upper front perspective partially exploded view of thepump system shown in FIG. 1A.

FIG. 1J is an alternative view of that shown in FIG. 1I, showing aportion of the fluid circuit of the pump system shown in FIG. 1A.

FIG. 1K is a side partially exploded view of the pump system shown inFIG. 1A.

FIG. 1L is an alternative view of that shown in FIG. 1K, showing aportion of the fluid circuit of the pump system shown in FIG. 1A.

FIG. 1M is a schematic view of the process involved in using the pumpsystem shown in FIG. 1A.

FIG. 1N is a schematic view of the control system for the pump systemshown in FIG. 1A.

FIG. 1O is a schematic view of operation of the pump system shown inFIG. 1A when the electrically activated pump and the mechanicallyactivated pump are in operation.

FIG. 1P is a schematic view of operation of the pump system shown inFIG. 1A when only the mechanically activated pump is in operation.

FIG. 2A is a side perspective view of a second example pump system for aprosthetic device.

FIG. 2B is a side view of the pump system shown in FIG. 2A

FIG. 2C is a lower rear perspective view of the pump system shown inFIG. 2A.

FIG. 2D is an upper front perspective view of the pump system shown inFIG. 2A.

FIG. 2E is an upper front perspective partially exploded view of thepump system shown in FIG. 2A.

FIG. 2F is an alternative view of that shown in FIG. 2E, showing view ofa layout of major components within the electrically activated pump ofthe pump system shown in FIG. 2E.

FIG. 3A is an upper perspective view of a third pump system for aprosthetic device.

FIG. 3B is a front view of the pump system shown in FIG. 3A.

FIG. 3C is a side view of the pump system shown in FIG. 3A.

FIG. 3D is an upper front perspective partially exploded view of thepump system shown in FIG. 3A.

FIG. 3E is a simplified upper perspective view of a layout of majorcomponents within the electrically activated pump of the pump systemshown in FIG. 3A.

FIG. 4A is a simplified side view of a prosthetic device in the form ofa prosthetic limb for a transfemoral amputee having a fourth examplepump system that includes a mechanically activated pump.

FIG. 4B is a simplified side view of a prosthetic device in the form ofa prosthetic limb for a transtibial amputee having the pump system shownin FIG. 4A.

FIG. 4C is a rear view of the pump system shown in FIG. 4A.

FIG. 4D is a side view of the pump system shown in FIG. 4A.

FIG. 4E is an upper perspective view of the pump system shown in FIG.4A.

FIG. 4F is a lower perspective view of the pump system shown in FIG. 4A.

FIG. 4G is a lower rear perspective partially exploded view of the pumpsystem shown in FIG. 4A.

FIG. 4H is a simplified upper perspective view of an upper compressionmember of the pump system shown in FIG. 4A and further including anelectrically activated pump that is shown with a layout of the majorcomponents.

It should be understood that the drawings are not to scale. While somedetails of a pump system for a prosthetic device, including details offastening means and other plan and section views of the particularcomponents, have not been included, such details are considered wellwithin the comprehension of those of skill in the art in light of thepresent disclosure. It also should be understood that the presentinvention is not limited to the example embodiments illustrated.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring generally to FIGS. 1A-4H, it will be appreciated that a vacuumpump system for use in suspension of a prosthetic device from a residuallimb of the present disclosure generally may be embodied within numerousconfigurations of pump systems having a mechanically activated pumpand/or a hybrid pump system having a mechanically activated pump and anelectrically activated pump. Indeed, while acknowledging that all of theexample configurations may include at least one of the examplemechanically activated pumps, it is contemplated that a pump system maybe incorporated into various prosthetic devices, such as transfemoraland transtibial prosthetic limbs.

FIG. 1A shows a simplified side view of a prosthetic device or limb 2 inthe form of a prosthetic limb for a transfemoral amputee. The prostheticdevice 2 generally includes a socket 4, a first example pump system 6, aknee joint 8, a pylon 10 and a prosthetic foot 12. The socket 4 has anupper end 18 that is open and is adapted to receive a transfemoralresidual limb, with a lower end 20 that includes a port (not shown) influid communication with the pump system 6.

FIG. 1B incorporates somewhat similar components in showing a simplifiedside view of a prosthetic device or limb 2′ in the form of a prostheticlimb for a transtibial amputee. The prosthetic device 2′ generallyincludes a socket 4′, the first example pump system 6, a pylon 10′ and aprosthetic foot 12. The socket 4′ has an upper end 18′ that is open andis adapted to receive a transtibial residual limb, with a lower end 20′that includes a port (not shown) in fluid communication with the pumpsystem 6.

There are numerous configurations of socket assemblies for suspensionsystems, some custom molded and constructed for direct contact with theskin of the residual limb, while others are intended to receive aresidual limb that is covered with one or more liner components thatprevent the skin from direct contact with the socket and exposure tovacuum pressure developed within the socket. It will be appreciated thatthe pump systems of the present disclosure could be configured for usein prosthetic devices with either type of socket, whether for use withtransfemoral or transtibial residual limbs, with the components andspecifications being appropriately matched to the desired vacuumpressure. Indeed, the specific construction and shape of the socket arenot at issue, and depending on the particular configuration used, theport may be placed at various locations within the socket.

Although shown in simplified form, it will be understood that within aprosthetic device 2, 2′, the lower end 20, 20′ of the socket 4, 4′ willinclude a mounting flange and associated fasteners, or other connectiveelements, for connection to the pump system 6 or to other intermediarycomponents. Similarly, the upper end of the knee joint 8 or pylon 10′will be equipped for connection to the pump system 6, such as by havinga mounting flange for a standard pyramid four bolt connector. It will beappreciated that the low profile, inline structure of the pump system 6may be incorporated into a reduced package height, preferably althoughnot necessarily of about 1.5 inches or less, which permits fluidconnection of the pump system 6 to the lower end 20, 20′ of the socket4, 4′, and may eliminate the need for external tubing. Avoiding the useof external tubing can reduce the likelihood of interference orimpedance of flexion of the knee, or the risk of getting caught on aprotrusion.

A pump system 6 consistent with the first example may be seen in variousviews within FIGS. 1C-1L and includes at least a mechanically activatedpump 30. As shown, the first example also includes an electricallyactivated pump 70, and the mechanically activated pump 30 andelectrically activated pump 70 are connected within a fluid circuit 90that is connected to and adapted to evacuate air from the socket 4, 4′,thereby forming a particularly advantageous modular, hybrid pump system6. The evacuation of air from the socket 4, 4′, provides vacuumengagement between the prosthetic device 2, 2′ and a respectivetransfemoral or transtibial residual limb. It also will be appreciatedthat with a pump system that includes a mechanically activated pump 30,the pump system alternatively could be configured for periodic use witha separate hand operated pump to establish initial air evacuation.

The hybrid pump system 6 of this first example provides a compact, lowprofile, inline structure. As may be seen in FIGS. 1C-1F and 1I-1L, themechanically activated pump 30 of the first example pump system 6includes a first compression member 32 coupled to a second compressionmember 34, with a compressible bladder 36 is disposed therebetween. Thefirst and second compression members 32, 34 preferably are constructedof relatively light weight, generally rigid, suitable metals, such asaluminum alloys, titanium alloys, stainless steels or superalloys, orvarious plastics or composite materials. Depending on the environment towhich a prosthetic device may be subjected, it may be desirable for thematerials to be waterproof, sand-proof, and weather and corrosionresistant, although an outer pump system cover also may be employed toreduce the likelihood of intrusion of fluids or foreign matter.

The first compression member 32 includes a generally planar central body38 having a central recess 40, spaced apart mounting apertures 42, andextensions in the form of hinge knuckles 44 that are opposite a flange46. The mounting apertures 42 are configured to permit fasteners to passtherethrough for mounting to a standard pyramid four bolt connector atthe upper end of a knee joint 8 or pylon 10′, but it will be appreciatedthat alternative connective elements could be integrally formed into thefirst compression member for this or the other examples. The secondcompression member 34 includes a generally planar central body 48 havinga central aperture 50, spaced apart mounting apertures 52, and anextension in the form of a hinge knuckle 54 that is opposite a flange56. The first compression member 32 is coupled to the second compressionmember 34 via coupling elements that include a the hinge knuckles 44, 54and a hinge pin 58 that pivotally engages the respective knuckles 44,54, thereby making the first compression member 32 pivotally coupled tothe second compression member 34. An optional spring assembly 60 extendsbetween the respective flanges 46, 56 and biases the flanges toward aspaced apart position. Use of the spring assembly 60 may assist inproviding consistent operation and feedback to the user.

While the coupling elements may be of a different configuration andsize, the mechanically activated pump 30 should provide sufficientstructural integrity and stability to maintain a consistent andpredictable gait and resistance to torsional inputs, such as a twistingmotion after planting a step. Also, it will be appreciated that thehinge or pivotal coupling is shown on the anterior or front side of thepump. While the hinge could be placed anteriorly or posteriorly,depending on the preference of particular prosthetists, placementanteriorly should cause the bladder to compress upon heel contact,providing some shock absorption, and movement of the pivots should mimica desirable stance phase knee flexion.

The compressible bladder 36 may be particularly effective, while beingof relatively short height because it has nearly continuous generallyplanar upper and lower surfaces 36′, 36″, which are connected to aradially bulging outer sidewall 36′″ that defines an outer perimeter ofthe compressible bladder 36. This configuration of the compressiblebladder 36 permits much greater capacity, and therefore potentialefficiency, within a given overall diameter, when compared to acompressible bladder having an enlarged passage through the center toaccommodate a tubular pylon-like telescopic structure. Locating the pumpsystem 6 above the knee in a transfemoral configuration may permit arelatively large overall diameter, such as around 4 inches.

The compressible bladder 36 generally is an airtight, elastomeric body,and depending on the extent of the desired inherent rebound within thestructure, and the anticipated environmental conditions, may beconstructed of various rubbers, such as plasticized Halobutyl orpolysulphide rubbers, plastics, such as ABS, PEEK or other polymers,Nylon, composites or other suitable materials. Also, depending on theselected material, the compressible bladder may be constructed by blowmolding or other suitable manufacturing techniques.

While the compressible bladder 36 may be constructed of one or morematerials and in a manner that will tend to expand or return to itsoriginal non-compressed state, thereby separating the first and secondcompression members 32, 34, the optional spring assembly 60 is intendedto ensure rebound and expansion of the compressible bladder 36 duringrepeated hinged compression movements that occur during walking orisolated bouncing-type movements. Also, it will be appreciated that manyconfigurations of compression members, compressible bladders andcoupling elements may be utilized to couple a first compressible memberto a second compressible member, and optional spring assemblies mayinclude alternative spring forms, including for example, a leaf spring,or a coiled torsion spring having opposed arms and being incorporatedwith a hinge pin, or other suitable alternative structures.

The first and second compression members 32, 34 and compressible bladder36 utilize a fluid circuit 90 to evacuate air from the socket 4, 4′. Thecompressible bladder 36 includes an intake valve 62 that communicatesthrough the aperture 50 in the second compression member 34, and anoutput valve 64 that is vented to the atmosphere to expel air that hasbeen evacuated from the socket 4, 4′ by the pump system 6.

In the first example, the electrically activated pump 70 is positionedinline with and connected to the second compression member 34 of themechanically activated pump 30. As may be seen in a simplified manner inFIGS. 1L and 1J, the electrically activated pump 70 includes a housing72 having an inlet valve 74 in communication with a central passage 76therethrough for fluid connection to the socket 4, 4′, and an outputvalve 78 that is vented to the atmosphere to expel air that has beenevacuated from the socket 4, 4′ by the pump system 6. The housing 72also includes passages 80 therethrough that are aligned with themounting apertures 52 in the second compression member 34 and togetherreceive fasteners (not shown) that provide mechanical connection of themechanically activated pump 30 and electrically activated pump 70 to asuitable mounting flange (not shown) at the lower end 20, 20′ of asocket 4, 4′. It will be appreciated that the electrically activatedpump may be equipped with alternative valving and operative features, asdesired. Also, the housing of the electrically activated pump could beconfigured to be integrated into the lower end of a socket.

As may be appreciated in FIGS. 1G, 1H and 1N, the electrical componentsof the electrically activated pump 70 are shown in a simple layout andwith a functional schematic to show the basic function and connectionconfiguration. It will be appreciated that the components may beconfigured and connected in fluid communication by conventional means,such as by suitable tubing, and/or may be configured and connectedelectrically by conventional means, such as by suitable wires, leads orother circuitry, so as to meet the needs and satisfy the designspecifications and constraints within of a particular implementation. Inthis first example, within the housing 72 of the electrically activatedpump 70 is a microcontroller M that includes a circuit board and isconnected to a motorized pump MP, a pressure sensor PS, and a batteryBAT. A user interface A, in the form of an on/off button, is located inconjunction with the output valve 78 and is connected to themicrocontroller M. An optional serial data port D may be utilized tointeract with the microcontroller M, such as to track and record theoperating conditions of the pump system 6, for diagnostic and historicalmonitoring purposes.

A further user interface B, such as in the form of a wireless remotecontrol device, a personal data assistant device, a laptop or tabletcomputer, a cell phone or other wireless apparatus, may be utilized tointeract with the microcontroller M to input particular settings thatare associated with performance parameters, such as the minimum andmaximum vacuum pressures between which the system will operate, thebattery charge level at which a warning light or alarm may be emitted,or to adjust other parameters that would be desirable to control. Theuser interface B also may be used to display information associated withthe present status of the system, such as the current vacuum pressurelevel, battery charge level, or predictive information, such as thebattery life remaining or time interval until the next regularmaintenance is recommended. The pump system 6 may include warning lightsor alarms that may be connected to the housing 72, or embodied within auser interface B, to alert a user to important information.

The battery BAT preferably is rechargeable, such as by direct orindirect connection to a power charge device PC. It further is desirablethat the battery BAT be replaceable, so as to permit one or more spare,charged batteries to be utilized during periods of extended use awayfrom a power recharging source. It will be appreciated that the batteryBAT may simply be of a disposable type, or that there could be aninterface to permit interchangeability between a rechargeable batteryand a disposable battery, based on the convenience and circumstancesfaced by the user.

It will be appreciated that the pump system 6 presents a hybrid, modularsystem that can be utilized in a number of ways. A high level schematicis provided in FIG. 1M to show that when the residual limb of a user hasbeen received in a socket 4, 4′, the user is faced with an input thatessentially could be considered an unevacuated chamber. The user thenmay take one of two actions, namely, first to press a button, such asuser interface button A on the housing 72, or on a user interface B,such as a remote control, to provide electrical power to engage theelectrically activated pump 70, or second to step with the prostheticlimb 2, 2′ to provide mechanical power to the mechanically activatedpump 30. The two different actions both cause the pump system 6 toprovide a response by which air is expelled to the atmosphere, resultingin an outcome by which the chamber between the socket 4, 4′ and theresidual limb changes to an evacuated chamber.

Thus, the mechanically activated pump 30 or the electrically activatedpump 70 may be used to evacuate air from the socket 4, 4′, with theunderstanding that either pump may be used exclusively, if need be.However, maximum comfort and convenience can be achieved by firstutilizing the electrically activated pump 70 to establish rapid initialevacuation, and thereafter the user may rely on the mechanicallyactivated pump 30, if the user is actively moving, such as walking,running or able to impose at least a bouncing motion on the prostheticlimb 2, 2′, or if the user happens to be inactive at a time when furtherevacuation of air is needed, the monitoring system within theelectrically activated pump 70 may automatically engage the motorizedpump MP to reestablish an acceptable vacuum pressure.

FIG. 1O provides a schematic representation of the pump system 6 when auser is walking and the pump system 6 is within an electricalpump-vacuum control range. Thus, within a swing phase, the first andsecond compressible members 32, 34 move away from each other, allowingthe compressible bladder 36 to expand and draw air from the socket 4,4′. Meanwhile, the electrically activated pump 70 may draw air from thesocket 4, 4′ and expel the air to the atmosphere through the outputvalve 78. Within the stance phase, the compression member 32 pivotsrelative to the compression member 34 to compress the compressiblebladder 36, expelling the air previously withdrawn from the socket 4,4′, while the electrically activated pump 70 is able to continue tooperate in the same manner as during the swing phase.

FIG. 1P provides a schematic representation of the pump system 6 when auser is walking and the pump system 6 is outside of an electricalpump-vacuum control range. While the schematic represents portions ofthe fluid circuit 90 as elongated lines, it will be appreciated that theconnections between components may be direct, or may be by tubing, andthat tubing could be used in a configuration of a prosthetic devicehaving a socket 4 for a transfemoral residual limb, with a pump system 6positioned below the knee joint. Within the swing phase shown in FIG.1P, the first and second compressible members 32, 34 again move awayfrom each other, allowing the compressible bladder 36 to expand and drawair from the socket 4, 4′. Meanwhile, the electrically activated pump 70is not energized, to save battery charge. Within the stance phase, thecompression member 32 pivots relative to the compression member 34 tocompress the compressible bladder 36, expelling the air previouslywithdrawn from the socket 4, 4′.

From the foregoing description, it will be appreciated that a method ofsuspending a prosthetic device 2, 2′ from a residual limb is providedherein. The method includes providing a prosthetic device 2, 2′ having asocket 4, 4′ that receives the residual limb. The method furtherincludes providing a mechanically activated pump 30 having a firstcompression member 32 coupled to a second compression member 34, acompressible bladder 36 disposed between the first and secondcompression members 32, 34. The coupling elements include the hingeknuckles 44, 54 and the hinge pin 58 which engages and couples togetherthe first and second compression members 32, 34, wherein all of thecoupling elements are disposed about an outer perimeter that is definedby the sidewall 36′″ of the compressible bladder 36, such that thecoupling elements are at or beyond the outer perimeter of thecompressible bladder 36. The method also includes providing a fluidcircuit 90 in communication with the socket 4, 4′ and the compressiblebladder 36, the fluid circuit 90 being configured to evacuate air fromthe socket 4, 4′ when operating the mechanically activated pump 30.Operation of the mechanically activated pump 30 occurs when theprosthetic device 2, 2′ is used to walk.

Turning to FIGS. 2A-2F, a second example pump system 106 is disclosedfor use in a prosthetic device, such as the prosthetic devices 2, 2′.The pump system 106 is quite similar to the first example pump system 6,but varies somewhat in the mechanically activated pump 130 that replacesthe mechanically activated pump 30. However, the second example pumpsystem 106 also includes at least a mechanically activated pump 130, andis equipped with an electrically activated pump 70. The mechanicallyactivated pump 130 and electrically activated pump 70 are connectedwithin a fluid circuit that is similar to the fluid circuit 90 and isconnected to and adapted to evacuate air from the socket 4, 4′, therebyforming a particularly advantageous hybrid pump system 106. Theevacuation of air from the socket 4, 4′, provides vacuum engagementbetween the prosthetic device 2, 2′ and a respective transfemoral ortranstibial residual limb.

The hybrid pump system 106 similarly provides a compact, low profile,inline structure, where the mechanically activated pump 130 includes afirst compression member 132 coupled to a second compression member 134,which preferably are constructed of materials similar to those mentionedwith respect to the first example pump system 6. A compressible bladder136 is disposed between the first and second compression members 132,134.

The first compression member 132 includes a generally planar centralbody 138 having a central recess 140, spaced apart mounting apertures142, and extensions in the form of hinge knuckles 144 that are oppositea flange 146. The second compression member 134 includes a generallyplanar central body 148 having a central aperture 150, spaced apartmounting apertures 152, and an extension in the form of a hinge knuckle154 that is opposite a flange 156. The first compression member 132 iscoupled to the second compression member 134 via coupling elements thatinclude a the hinge knuckles 144, 154 and a hinge pin 158 that pivotallyengages the respective knuckles 144, 154, thereby making the firstcompression member 132 pivotally coupled to the second compressionmember 134. An optional strap 159 is connected, such as by rivets,screws or other fasteners, to the respective flanges 146, 156, extendsbetween them and limits the pivotal travel of the first compressionmember 132 relative to the second compression member 134. In this secondexample pump system 106, an optional spring assembly 160 extends througha central opening 176 in the compressible bladder 136 between and biasesthe respective bodies 138, 148 toward a spaced apart position. It willbe appreciated that the optional spring assembly 160 also would not beneeded if the strap 159 alternatively incorporated a spring element.

The compressible bladder 136 may be particularly effective, while beingof relatively short height because it has nearly continuous generallyplanar upper and lower surfaces 136′, 136″, which are connected to aradially bulging outer sidewall 136′″ that defines an outer perimeter ofthe compressible bladder 136. As with the first example pump system 6,the coupling elements of the second pump system 106 are disposed aboutthe outer perimeter of the compressible bladder 136. This configurationof the compressible bladder 136 permits much greater capacity within agiven overall diameter, when compared to a compressible bladder havingan enlarged passage through the center to accommodate a tubularpylon-like telescopic structure. The compressible bladder 136 generallyis elastomeric and may be constructed of materials similar to thosementioned above with respect to the first example pump system 6.

While the compressible bladder 136 may be constructed of one or morematerials and in a manner that will tend to expand to a non-compressedstate, thereby separating the first and second compression members 132,134, the optional spring assembly 160 is intended to ensure rebound andexpansion of the compressible bladder 136 during repeated hingedcompression movements that occur during walking or isolatedbouncing-type movements. Also, it will be appreciated that manyconfigurations of compression members, compressible bladders andcoupling elements may be utilized to couple a first compressible memberto a second compressible member, and optional spring assemblies mayinclude alternative spring forms, such as are mentioned above withrespect to the first example pump system 6.

The first and second compression members 132, 134 and compressiblebladder 136 utilize a fluid circuit 190 to evacuate air from the socket4, 4′. The fluid circuit 190 is similar to the fluid circuit 90 of thefirst example pump system 6, but the compressible bladder 136incorporates an intake valve (not shown) that communicates through theaperture 150 in the second compression member 134, and an output valve(not shown) that is vented to the atmosphere to expel air that has beenevacuated from the socket 4, 4′ by the pump system 106.

In the second example, the electrically activated pump 70 is positionedinline with and connected to the second compression member 134 of themechanically activated pump 130. As shown in a simplified manner, theelectrically activated pump 70 is essentially the same as that shown inthe first example pump system 6 and operates in the same way. Thehousing 72 of the electrically activated pump 70 includes passages 80therethrough that are aligned with the mounting apertures 152 in thesecond compression member 134 and together receive fasteners (not shown)that provide mechanical connection of the mechanically activated pump130 and electrically activated pump 70 to a suitable mounting flange(not shown) at the lower end 20, 20′ of a socket 4, 4′.

As may be best appreciated in FIG. 2F, the electrical components of theelectrically activated pump 70 are shown in a simple layout, and it willbe appreciated that the components may be configured and connected in amanner similar to that discussed above with respect to the first examplepump system 6. The pump system 106 also may utilize similar userinterfaces, operations and methods of use to those described above withrespect to the schematic diagrams provided for the first example pumpsystem 6.

Turning to FIGS. 3A-3E, a third example pump system 206 is disclosed foruse in a prosthetic device, such as the prosthetic devices 2, 2′. Thepump system 206 is somewhat similar to the second example pump system106, but varies in the mechanically activated pump 230 that replaces themechanically activated pump 130. However, the third example pump system206 also includes at least a mechanically activated pump 230, and isequipped with an electrically activated pump 70 that is similar to thatused in the first example pump system 6. The mechanically activated pump230 and electrically activated pump 70 are connected within a fluidcircuit that is similar to the fluid circuit 90 and is connected to andadapted to evacuate air from the socket 4, 4′, thereby forming aparticularly advantageous hybrid pump system 206. The evacuation of airfrom the socket 4, 4′, provides vacuum engagement between the prostheticdevice 2, 2′ and a respective transfemoral or transtibial residual limb.

The hybrid pump system 206 similarly provides a compact, low profile,inline structure, where the mechanically activated pump 230 includes afirst compression member 232 coupled to a second compression member 234,which preferably are constructed of materials similar to those mentionedwith respect to the first example pump system 6. A compressible bladder236 is disposed between the first and second compression members 232,234.

The first compression member 232 includes a generally planar centralbody 238 having a central recess (not shown), spaced apart mountingapertures 242, and an extension 244 that is generally perpendicular tothe central body 238 and has a pair of parallel bores 246 extendingtherethrough. The second compression member 234 includes a generallyplanar central body 248 having a central aperture 250, spaced apartmounting apertures 252, and an extension 254 that is generallyperpendicular to the central body 248 and has a pair of parallel bores256 extending therethrough. The respective pairs of parallel bores 246,256 are parallel to each other and each bore is aligned with a furtherbore 255 through an end of a respective parallel upper or lower link257. Pairs of pivot pins 258 are received by the respective pairs ofbores 246, 256 in the first and second compression members 232, 234, andare pivotally connected to the bores 255 at the ends of the links 257.

The parallel links 257 permit the first and second compression members232, 234 to be pivotally coupled to each other, but form a four barlinkage that also causes the first compression member 232 to translatetoward and away from the second compression member 234, whilemaintaining a relative parallel orientation of the generally planarcentral bodies 238, 248. This compact, low profile configurationpresents a further alternative that may utilize the same shorter height,yet higher capacity compressible bladder 136 that is used in the secondexample pump system 106. Accordingly, the compressible bladder 136 isdisposed between the first and second compression members 232, 234, andutilizes an optional spring assembly 160 that extends through a centralopening 176 in the compressible bladder 136 and assists in biasing therespective central bodies 238, 248 toward a spaced apart position. Itwill be appreciated that the coupling elements include the extensions244, 254, the pivot pins 258 and the links 257.

The compressible bladder 136 may be particularly effective, while beingof relatively short height because it has nearly continuous generallyplanar upper and lower surfaces 136′, 136″, which are connected to aradially bulging outer sidewall 136′″ that defines an outer perimeter ofthe compressible bladder 136. In this configuration, as with the priorexamples, the coupling elements are disposed generally outside of orabout the outer perimeter of the compressible bladder 136. This permitsmuch greater capacity within a given overall diameter, when compared toa compressible bladder having an enlarged passage through the center toaccommodate a tubular pylon-like telescopic structure. The compressiblebladder 136 generally is elastomeric and may be constructed of materialssimilar to those mentioned above with respect to the first example pumpsystem 6. The first and second compression members 232, 234 andcompressible bladder 136 utilize a fluid circuit that is the same as thefluid circuit 190 in the second example pump system to evacuate air fromthe socket 4, 4′.

While the compressible bladder 136 may be constructed of one or morematerials and in a manner that will tend to expand to a non-compressedstate, thereby separating the first and second compression members 232,234, the optional spring assembly 160 is intended to ensure rebound andexpansion of the compressible bladder 136 during repeated hingedcompression movements that occur during walking or isolatedbouncing-type movements. Also, it will be appreciated that manyconfigurations of compression members, compressible bladders andcoupling elements may be utilized to couple a first compressible memberto a second compressible member, and optional spring assemblies mayinclude alternative spring forms, such as are mentioned above withrespect to the first example pump system 6.

In the third example, the electrically activated pump 70 is positionedinline with and connected to the second compression member 234 of themechanically activated pump 230. As shown in a simplified manner, theelectrically activated pump 70 is essentially the same as that shown inthe first and second example pump systems 6, 106 and operates in thesame way. The housing 72 of the electrically activated pump 70 includespassages 80 therethrough that are aligned with the mounting apertures252 in the second compression member 234 and together receive fasteners(not shown) that provide mechanical connection of the mechanicallyactivated pump 230 and electrically activated pump 70 to a suitablemounting flange (not shown) at the lower end 20, 20′ of a socket 4, 4′.

A simple schematic representation of the layout of the electricalcomponents of the electrically activated pump 70 was previously providedwith respect to the first example pump system 6, but is included againfor convenience in FIG. 3E. Accordingly, it will be appreciated that thecomponents of the third example pump system 206 may be configured andconnected in a manner similar to that discussed above with respect tothe first example pump system 6. The pump system 206 also may utilizesimilar user interfaces, operations and methods of use to thosedescribed above with respect to the schematic diagrams provided for thefirst example pump system 6. It further will be appreciated that thelinkage and first and second compression members 232, 234 that provideparallel relative displacement, with a compressible bladder 136therebetween, may achieve advantages over pumps utilized in othercontexts and configurations.

Turning to FIGS. 4A-4H, a fourth example is provided, with the exampleinitially including only a mechanically activated pump in FIGS. 4A-4G,and then in FIG. 4H showing further coupling to and inclusion of anelectrically activated pump to form a modular, hybrid pump system.

FIG. 4A shows a simplified side view of a prosthetic device or limb 302in the form of a prosthetic limb for a transfemoral amputee. Theprosthetic device 302 generally includes a socket 4, a fourth examplepump system 306, a knee joint 8, a pylon 10 and a prosthetic foot 12.The socket 4 has an upper end 18 that is open and is adapted to receivea transfemoral residual limb, with a lower end 20 that includes a port(not shown) in fluid communication with the pump system 306. It will beappreciated that aside from the pump system 306, the other components ofthe prosthetic limb 302 are the same as those of the previouslydescribed prosthetic limb 2.

FIG. 4B incorporates in a prosthetic device 302′ the same components asshown in the simplified side view of a prosthetic device or limb 2′, inthe form of a prosthetic limb for a transtibial amputee. The prostheticdevice 302′ generally includes a socket 4′, the fourth example pumpsystem 306, a pylon 10′ and a prosthetic foot 12. The socket 4′ has anupper end 18′ that is open and is adapted to receive a transtibialresidual limb, with a lower end 20′ that includes a port (not shown) influid communication with the pump system 306.

The disclosure provided previously relating to the sockets 4, 4′ andother components of prosthetic devices apply to and will not be repeatedfor this fourth example. Thus, though not shown in the simplifieddrawings, it will be understood that the prosthetic devices 302, 302′would include mounting flanges or other hardware to accommodate mountingof the pump system 306 to the socket 4, 4′ and to the upper end of theknee joint 8 or pylon 10′. Nevertheless, the fourth example prostheticdevices 302, 302′ also embody low profile, inline structures with a pumpsystem 306 that may be incorporated into a reduced package height, asdiscussed with the other examples. This would permit fluid connection ofthe pump system 306 to the lower end 20, 20′ of the socket 4, 4′, andmay eliminate the need for external tubing, having the advantages ofsuch previously noted with respect the first example.

A fourth example pump system 306 may be seen in various views withinFIGS. 4C-4H and includes at least a mechanically activated pump 330. Asshown in FIG. 4H, the fourth example also may include an electricallyactivated pump 370. The mechanically activated pump 330 and electricallyactivated pump 370 may be connected within a fluid circuit 390, aportion of which is shown, but which is connected to and adapted toevacuate air from the socket 4, 4′ in a similar manner to that shown inthe first example, thereby forming a particularly advantageous modular,hybrid pump system. The evacuation of air from the socket 4, 4′,provides vacuum engagement between the prosthetic device 2, 2′ and arespective transfemoral or transtibial residual limb. It also will beappreciated that with a pump system that includes a mechanicallyactivated pump 330, the pump system alternatively could be configuredfor periodic use with a separate hand operated pump to establish initialair evacuation.

The hybrid pump system of this fourth example provides a compact, lowprofile, inline structure, and takes advantage of space provided at thefront of the knee. As may be seen in FIGS. 4C-4H, the mechanicallyactivated pump 330 of the fourth example pump system 306 includes afirst compression member 332 coupled to a second compression member 334,with the compressible bladder 36 of the first example being disposedtherebetween. The first and second compression members 332, 334preferably are constructed of relatively light weight, generally rigidmaterials, such as discussed with respect to the first example.

The first compression member 332 includes a generally planar centralbody 338 having a central recess (not shown), spaced apart mountingapertures 342, and extensions 344 having bores 345 therethrough andbeing generally perpendicular to the central body 338. The secondcompression member 334 includes a generally planar central body 348having a central aperture 350, spaced apart mounting apertures 352, andan extension in the form of a flange 354 that extends upward and forwardfrom the central body 348. The first compression member 332 is coupledto the second compression member 334 via coupling elements that includefour respective fastener pins 356 that may be connected to the secondcompressible member 334 at apertures 358, such as by press fit or othersuitable means of connection, and that slide within the bores 345 of theextensions 344 of the first compression member 332. This couplingconfiguration provides for translation of the second compression member334 relative to the first compression member 332. While the couplingelements may be of a different configuration and size, the mechanicallyactivated pump 330 should provide sufficient structural integrity andstability to maintain a consistent and predictable gait and resistanceto torsional inputs, such as a twisting motion after planting a step.Optional springs 360 may be placed around the extensions 344 and extendbetween and first and second compression members 332, 334, tending tobias them toward a spaced apart position. Use of the springs 360 mayassist in providing consistent operation and feedback to the user.

The compressible bladder 36 and its associated valving may beparticularly effective in this example, as well, in light of therelatively short height, and nearly continuous generally planar upperand lower surfaces that are connected to the radially bulging outersidewall 36′″. As with the prior examples, the outer sidewall defines anouter perimeter of the compressible bladder 36 and such a configurationfor a compressible bladder 36 may permit greater capacity and potentialefficiency, within a given overall diameter, when compared to acompressible bladder having an enlarged passage through the center toaccommodate a tubular pylon-like telescopic structure. This fourthexample similarly has all of the coupling elements disposed about anouter perimeter that is defined by the sidewall 36′″ of the compressiblebladder 36, such that the coupling elements are at or beyond the outerperimeter of the compressible bladder 36. This permits a shorter pumpheight and location of the pump system 306 above the knee in atransfemoral configuration, which in turn, may permit a relatively largeoverall diameter and capacity for the compressible bladder.

As noted previously, the compressible bladder 36 may be constructed ofone or more materials and in a manner that will tend to expand or returnto its original non-compressed state, thereby separating the first andsecond compression members 332, 334. However, the optional springs 360are intended to ensure rebound and expansion of the compressible bladder36 during repeated telescopic compression movements that occur duringwalking or isolated bouncing-type movements. Also, as previously noted,it will be appreciated that many configurations of compression members,compressible bladders and coupling elements may be utilized to couple afirst compressible member to a second compressible member, and optionalspring assemblies may include alternative spring forms, including forexample, a leaf spring, or coiled torsion springs having opposed armsand being positions to bias the first and second compression members332, 334 to a spaced apart position. Given the number of couplingelements and their spaced arrangement, it is believed that a central,relatively long and large tubular telescopic assembly need not berequired, and that the shorter, thinner fastener pins 356 sliding withinthe bores 345 of the extensions 344 will provide for proper alignmentand smooth translational movement.

The first and second compression members 332, 334 and compressiblebladder 36 utilize a fluid circuit that would be comparable to thosepreviously described to evacuate air from the socket 4, 4′ of theprosthetic devices 302, 302′. As noted, the compressible bladder 36includes an intake valve, and it is able to communicate through anaperture 350 in the second compression member 334, and an output valveis vented to the atmosphere to expel air that has been evacuated fromthe socket 4, 4′ by the pump system 306.

In the fourth example, the electrically activated pump 370 is positionedessentially above and forward of the knee joint 8 or the pylon 10′,connected to the flange 354 of the second compression member 334 of themechanically activated pump 330. As may be seen in a simplified mannerin FIG. 4H, the electrically activated pump 370 includes a housing 372having an inlet valve 374 in communication with the central aperture 350of the second compression member 334 for fluid connection to the socket4, 4′, and an output valve (not shown) that is vented to the atmosphereto expel air that has been evacuated from the socket 4, 4′ by the pumpsystem 306. The housing 372 also includes mounting bores 378 thatreceive fasteners (not shown) through passages 380 in the central body348 of the second compression member 334 to connect the electricallyactivated pump 370 to the mechanically activated pump 330. It will beappreciated that the electrically activated pump may be equipped withalternative valving and operative features, as desired. Also, thehousing of the electrically activated pump could be configured to beconnected to the mechanically activated pump in an alternative manner,such as for example, in the stacked arrangement shown in the first threeexamples, just as any of those examples could have utilized a sidemounting of their respective electrically activated pumps, such as inthe manner shown with the fourth example or in an alternativeconfiguration that places the electrically activated pump outside of theouter perimeter of the compressible bladder. It also will be appreciatedthat an additional reduction in height may be achieved if the circuitryis positioned along the outer perimeter of the first and/or secondcompression member.

As may be appreciated in FIG. 4H, the electrical components of theelectrically activated pump 370 are shown in a simple layout and it willbe understood that they have similar basic functions and connectionconfigurations those described for the first example pump system 6 andwhich also would apply to the other examples. It will be appreciatedthat the components may be configured and connected in fluidcommunication by conventional means, such as by suitable tubing, and/ormay be configured and connected electrically by conventional means, suchas by suitable wires, leads or other circuitry, so as to meet the needsand satisfy the design specifications and constraints within of aparticular implementation. In this fourth example, within the housing372 of the electrically activated pump 370 is a microcontroller M′ thatincludes a circuit board and is connected to a motorized pump MP′, apressure sensor PS′, and a battery BAT′. A user interface A′, in theform of an on/of button, is located along the top of the flange 354 andis connected to the microcontroller M′. An optional serial data port D′may be utilized to interact with the microcontroller M′, such as totrack and record the operating conditions of the pump system 306, fordiagnostic and historical monitoring purposes.

As described with respect to the first example and would apply to theother examples, a further user interface, such as in the form of awireless remote control device or other devices may be utilized, aspreviously described. In addition, the battery BAT′ may be similar tothat which was described previously for the other examples.

It will be appreciated that, with inclusion of an electrically activatedpump 370, the pump system 306 may present a hybrid, modular system thatcan be utilized in a number of ways to evacuate air from a socket 4, 4′.Schematics provided for the first example, as well as the associateddescription, may be referred to and similarly apply to the means ofoperation and methods of use of the fourth example pump system 306 toestablish and maintain an evacuated chamber in the socket 4, 4′ of aprosthetic device 302, 302′, whether the mechanically activated pump 330is used alone, or is paired with the electrically activated pump 370 toprovide a hybrid pump system.

It will be appreciated that a pump system for use in suspension of aprosthetic device from a residual limb in accordance with the presentdisclosure may be provided in various configurations. Any variety ofsuitable materials of construction, configurations, shapes and sizes forthe components and methods of connecting the components may be utilizedto meet the particular needs and requirements of an end user. It will beapparent to those skilled in the art that various modifications can bemade in the design and construction of such pump systems withoutdeparting from the scope or spirit of the claimed subject matter, andthat the claims are not limited to the preferred embodiments illustratedherein.

What is claimed is:
 1. A pump system for use in suspension of aprosthetic device from a transtibial residual limb comprising: amechanically activated pump having pumping action that requires amechanical input via movement of the prosthetic device and having afirst compression member coupled to a second compression member; acompressible bladder disposed between the first and second compressionmembers; coupling elements that engage and couple together the first andsecond compression members, wherein all of the coupling elements aredisposed about an outer perimeter of the compressible bladder; and aseparate electrically activated pump having an electrical power sourceand pumping action that requires an electrical input from the electricalpower source, wherein the electrically activated pump is coupled withina fluid circuit with the compressible bladder and the mechanicallyactivated pump.
 2. The pump system in accordance with claim 1, whereinthe fluid circuit is configured to provide vacuum engagement with thetranstibial residual limb.
 3. The pump system in accordance with claim2, wherein the pump system is incorporated into a prosthetic device thatfurther comprises a socket that is configured to receive the transtibialresidual limb and the fluid circuit is connected to the socket.
 4. Thepump system in accordance with claim 1, wherein the first compressionmember is pivotally coupled to the second compression member.
 5. Thepump system in accordance with claim 1, wherein the first compressionmember translates relative to the second compression member.
 6. The pumpsystem in accordance with claim 1, wherein the electrically activatedpump is disposed outward from the outer perimeter of the compressiblebladder.
 7. The pump system in accordance with claim 1, wherein theelectrical power source further comprises a battery.
 8. The pump systemin accordance with claim 7, wherein the battery is rechargeable.
 9. Ahybrid pump system that includes a prosthetic device that is adapted forsuspension from a transtibial residual limb comprising: a prostheticdevice having a transtibial residual limb receiving socket; amechanically activated pump having pumping action that requires amechanical input via movement of the prosthetic device; a separateelectrically activated pump having an electrical power source andpumping action that requires an electrical input from the electricalpower source; the mechanically activated pump and electrically activatedpump being connected within a fluid circuit that evacuates air from thetranstibial residual limb receiving socket; and wherein the mechanicallyactivated pump further comprises a first compression member coupled to asecond compression member and an elastomeric member disposed between thefirst and second compression members and being in fluid communicationwith the fluid circuit.
 10. The hybrid pump system in accordance withclaim 9, wherein the electrical power source further comprises abattery.
 11. The hybrid pump system in accordance with claim 10, whereinthe battery is rechargeable.
 12. The hybrid pump system in accordancewith claim 9, wherein the elastomeric member further comprises acompressible bladder.
 13. The hybrid pump system in accordance withclaim 9, wherein the first compression member is pivotally coupled tothe second compression member.
 14. The hybrid pump system in accordancewith claim 9, wherein the first compression member translates relativeto the second compression member.
 15. The hybrid pump system inaccordance with claim 9, wherein the electrically activated pump isdisposed above or below the mechanically activated pump.
 16. The pumpsystem in accordance with claim 9, wherein the electrically activatedpump is disposed outward from the outer perimeter of the compressiblebladder.
 17. A hybrid pump system that includes a prosthetic device thatis adapted for suspension from a transtibial residual limb comprising: aprosthetic device having a transtibial residual limb receiving socket; amechanically activated pump having pumping action that requires amechanical input via movement of the prosthetic device; a separateelectrically activated pump having an electrical power source andpumping action that requires an electrical input from the electricalpower source; the mechanically activated pump and electrically activatedpump being connected within a fluid circuit that evacuates air from thetranstibial residual limb receiving socket; and wherein the mechanicallyactivated pump further comprises a first compression member coupled to asecond compression member, an elastomeric element disposed between thefirst and second compression members and being in fluid communicationwith the fluid circuit, and coupling elements engaging and couplingtogether the first and second compression members, wherein all of thecoupling elements are disposed about an outer perimeter of theelastomeric element.
 18. The hybrid pump system in accordance with claim17, wherein the fluid circuit is in communication with the socket andthe elastomeric element of the mechanically activated pump, and themechanically activated pump evacuates air from the socket when theprosthetic device is used to walk.
 19. The hybrid pump system inaccordance with claim 17, further comprising a controller and whereinthe fluid circuit and controller are configured to evacuate air from thesocket by operating the electrically activated pump when the prostheticdevice is not being used to walk and the air pressure within the socketis outside of a preselected range of values.
 20. The hybrid pump systemin accordance with claim 17, further comprising a controller and whereinthe fluid circuit and controller are configured to evacuate air from thesocket by operating the electrically activated pump when the transtibialresidual limb is initially received within the socket.
 21. The hybridpump system in accordance with claim 17, wherein a preselected level ofvacuum within the socket is maintained by operation of the mechanicallyactivated pump.
 22. The hybrid pump system in accordance with claim 17,wherein a preselected level of vacuum within the socket is maintained byoperation of the electrically activated pump.
 23. The hybrid pump systemin accordance with claim 17, wherein the first compression member ispivotally coupled to the second compression.
 24. The hybrid pump systemin accordance with claim 17, wherein the first compression membertranslates relative to the second compression member.
 25. The hybridpump system in accordance with claim 17, wherein at least one spring isdisposed between the first compression member and the second compressionmember.
 26. The hybrid pump system in accordance with claim 25, whereinthe at least one spring biases the first compression member toward aposition spaced apart from the second compression member.